Pooled Human Serum for Cell Culture

Before pooling, each individual donor unit is tested and found negative for Hepatitis B [HBsAg], Hepatitis C [Anti-HCV], and Human Immunodeficiency Virus [HIV] antibodies by ELISA. Final product is tested and found negative for HBsAg, Hepatitis A, and HIV. Biological performance is assessed using cell culture medium supplemented with the serum and tested at a final concentration of 10%. All human sera are tested for 7 days in culture and observed microscopically for normal morphology and cell growth. All virus testing is conducted by outside clinical laboratories that are licensed under the Clinical Laboratory Improvement Act (CLIA). Nevertheless, products of human origin should be considered potentially infectious and handled accordingly.